Integra NeuroSciences Launches NeuraWrap™ Nerve Protector
PLAINSBORO, N.J., Sept. 8, 2004 (PRIMEZONE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that Integra NeuroSciences has received 510(k) clearance from the United States Food and Drug Administration to market the NeuraWrap™ Nerve Protector in the United States. The NeuraWrap product enhances Integra's product offering for the treatment of peripheral nerve injuries. Integra is launching the NeuraWrap Nerve Protector this week at the American Society for Surgery of the Hand's 2004 Annual Meeting in New York City. Integra will sell this product domestically through both its NeuroSciences and Plastic and Reconstructive Surgery sales forces.
The NeuraWrap Nerve Protector is a collagen nerve repair conduit designed for the treatment of injured, compressed or scarred nerves. The NeuraWrap product provides a protective environment for nerve healing, serving as an interface between damaged nerves and surrounding tissue. It is the only product available in the United States that is marketed for wrapping injured peripheral nerves. Based on available procedure data, Integra estimates that the worldwide market for the repair of injured, compressed, and scarred peripheral nerves is approximately $60 million.
Integra launched the NeuraGen™ Nerve Guide, its first collagen peripheral nerve repair conduit, in 2001. NeuraGen™ is indicated for peripheral nerve repair in cases where a nerve is completely severed. Since 2001, close to 5,000 NeuraGen nerve guides have been implanted in patients worldwide. NeuraGen has been used in many procedures, including procedures to repair nerves in the upper and lower extremities and cranial and facial nerves, as well as procedures for brachial plexus reconstruction. Physicians have responded favorably to NeuraGen, noting that their patients have achieved the return of neurological function without experiencing adverse wound reactions or neuroma formation.
"Previously, the benefits of the NeuraGen Nerve Guide could only be delivered to peripheral nerve injuries in cases where the nerve was completely severed. The introduction of the new NeuraWrap device allows application of this technology for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue and to separate the suture line from the surrounding tissue following traditional microsurgical nerve repair," said Simon Archibald, Ph.D., Vice President of Research and Development and Clinical Affairs. "The NeuraWrap device, like our other devices for the repair and regeneration of tissue, is based on our proprietary extracellular matrix technologies. It is the continuing goal of Integra to meet the needs of the surgical community through the translation of basic science into clinical devices and to continually improve the design of existing devices."
Integra LifeSciences Holdings Corporation is a diversified medical technology company that develops, manufactures, and markets medical devices for use in a variety of applications. The primary applications for our products are neuro-trauma and neurosurgery, plastic and reconstructive surgery and general surgery. Integra is a leader in applying the principles of biotechnology to medical devices that improve patients' quality of life. Our corporate headquarters are in Plainsboro, New Jersey, and we have manufacturing and research facilities located throughout the world. We have approximately 1,100 employees. Please visit our website at (http://www.Integra-LS.com).
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the future use of the NeuraWrap Nerve Protector. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of physicians to use the NeuraWrap Nerve Protector may affect the prospects for its use in clinical procedures. In addition, the economic, competitive, governmental, technological and other factors identified under the heading "Factors Than May Affect Our Future Performance" included in the Business section of Integra's Annual Report on Form 10-K for the year ended December 31, 2003 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
CONTACT: Integra LifeSciences Holdings Corporation
John Bostjancic Maria Platsis Senior Director of Finance Director of Corporate Development (609) 936-2239 and Investor Relations jbostjancic@integra-ls.com (609) 936-2333 mplatsis@integra-ls.com